The registration process for medical device is governed by the Ministry
of Health's Department of Medical Equipment and Construction (DMEC) and Health
Services (HS). Take a look at the flow-chart and step-by-step guide on the registration process below:

Step 1:

Apply for a Marketing Authorization (MA) certificate. For foreign companies that do not have representative offices yet in Vietnam, appoint a Marketing Authorization Holder (MAH) in the territory. (See "Requirements for Organizations Declaring Applicable Standards" or "Applying for Registration of Free Sale of Medical Equipment in Vietnam.")

Step 2:

Classify the medical device, according to Circular 39/2016/TT-BYT: "Classification of Medical Equipment" dated October 28, 2016.

Medical equipment in Vietnam are
classified into 2 groups, which are divided into 4 types depending on the
possible levels of risk related to the design and production of such medical
equipment:

Group

Class

Risk level

1

A

Low

2

B

Lower average

C

Upper average

D

High

See "Requirements to be Satisfied by Organizations Conducting Classification of Medical Equipment."